NCT04913311 Predictive Biomarkers for Pneumonitis After Chemoradiotherapy and Immunotherapy in Patients With Non-small Cell Lung Cancer
| NCT ID | NCT04913311 |
| Status | Recruiting |
| Phase | — |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Lung Non-Small Cell Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2021-01-21 |
| Primary Completion | 2027-02-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2021-01-21 with a primary completion date of 2027-02-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study looks at the side effects of chemotherapy and radiation (chemoradiation) followed by immunotherapy in patients with non-small cell lung cancer, with a particular focus on lung inflammation (pneumonitis). By collecting blood, stool and saliva samples, and data from lung function tests, researchers may be able to create a database of information about treatment and side effects in patients with non-small cell lung cancer who are receiving chemoradiation followed by immunotherapy. The information gained from this study may also help researchers find signs of problems with lung function earlier rather than later, since lung function is checked more often than routine care. This may improve how quickly these issues can be treated, and future patients may benefit from what is learned.
Eligibility Criteria
Inclusion Criteria: * Newly-diagnosed NSCLC patients who will be undergoing concurrent chemotherapy and radiotherapy (XRT) followed by immune checkpoint inhibitors (CPI) therapy with durvalumab, as per the PACIFIC trial * Willing to undergo all treatment and evaluation at MD Anderson Cancer Center (MDACC) * Has access to a smartphone with the ability to transmit data via wireless connection or through their personal cellular plan * Able and willing to perform home spirometry (HS) weekly without absolute contraindications to performing spirometry
Contact & Investigator
Ajay Sheshadri
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT04913311 clinical trial?
This trial is open to participants of all sexes, studying Lung Non-Small Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04913311 currently recruiting?
Yes, NCT04913311 is actively recruiting participants. Visit ClinicalTrials.gov or contact M.D. Anderson Cancer Center to inquire about joining.
Where is the NCT04913311 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT04913311 clinical trial?
NCT04913311 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Ajay Sheshadri at M.D. Anderson Cancer Center. The trial plans to enroll 150 participants.